MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SET SCREW FOR PLATE HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	SD03.110.010
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part # sd03.110.010.Synthes lot # h398485.Supplier lot # n/a.Release to warehouse date: february 2, 2018.Manufactured by: synthes (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the complaint device was sent to jabil brandywine.The returned device is in like new condition with no damage.Functional test: yes: functional assessment can be performed, and the complaint condition is able to be reproduced.Both devices were unable to assemble.Documentation/specification: current and manufactured revisions no design issues or discrepancies were identified.Dimensional inspection: measurement taken are in millimeter (mm): conforms to specification.Investigation conclusion: the complaint regarding the function of the side set screw not fitting into the handle is confirmed, as it matches the reported condition, but upon further analysis it was determined not to be related to the manufacturing process for the following reason: the product passed all inspection criteria (100% visual and ctq features) and was found to be within specifications at the time it was released to the warehouse.The certificate of compliance from certifies that all product was manufactured in accordance with the product drawings, and no nonconformances related to the complaint condition were present for the lot.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the side set screw would not fit in the distal radius plate handle so it could not be assembled or used upon receipt.There was no patient and procedure involvement.This report involves one (1) set screw for plate holder.This is report 2 of 2 for (b)(4).

• Brand Name: SET SCREW FOR PLATE HOLDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12421968
• Report Number: 2939274-2021-05172
• Device Sequence Number: 3609641
• Product Code: LXH
• UDI-Device Identifier: 10886982274151
• UDI-Public: (01)10886982274151
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SD03.110.010
• Device Catalogue Number: SD03.110.010
• Device Lot Number: H398485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1